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Preventing Lymphedema in Patients Undergoing Surgical Treatment for Head and Neck Cancer Through Vein Reconstruction

NCT07694726 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-08-19

No results posted yet for this study

Summary

\* The goal of this clinical trial is to learn if facial vein reconstruction after neck dissection works to reduce rates of lymphedema in adults getting surgical treatment for head and neck cancer.

This is a trial which aims to improve the rate of lymphedema for patients undergoing treatment for head and neck cancer. Our aim is to re-establish venous flow across the facial vein to improve lymphatic drainage after neck dissection.

* The investigators will also evaluate lymphatic flow before and after facial vein reconstruction to determine if there is evidence of lymphedema.
* The main questions this study aims to answer are:

1. Does facial vein reconstruction after neck dissection improved lymphatic flow in head and neck cancer patients?
2. Determine if there are changes in lymphatic flow before and after facial vein reconstruction?

After the study is completed, the investigators will compare rates of lymphedema and quality of life in patients with facial vein preservation/reconstruction as compared to previous patients treated for head and neck cancer without facial vein reconstruction.

Participants will undergo the following:

1. Oncologic and reconstructive surgery as normal. No changes in cancer treatment will occur due to the study.
2. When necessary, participants will undergo facial vein reconstruction immediately after neck dissection
3. Visit the clinic once every 3 months for routine checkups and tests. This is typical for most patients treated for head and neck cancer including those not enrolled in the trial.
4. Fill out short questionnaires to help understand quality of life after head and neck cancer treatment
5. Undergo lymphography in the OR and at the 1-year mark in the office. This is a simple test performed without radiation exposure. It requires 3 very small skin injections to perform the test.

Conditions

Interventions

PROCEDURE

Facial Vein Reconstruction

Immediately after neck dissection, the facial vein will be assessed. If the vein has been ligated for the neck dissection, then the vein will be repaired. This may require vein graft and the use of a venous coupler. If the vein is intact after neck dissection, we can proceed without surgical intervention.

Sponsors & Collaborators

Principal Investigators

  • Shaum Sridharan, M.D. · Shaum Sridharan, Associate Professor, University of Pittsburgh Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-07-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07694726 on ClinicalTrials.gov